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A Study of Aleglitazar in Patients With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00388518
First received: October 16, 2006
Last updated: November 1, 2016
Last verified: November 2016
October 16, 2006
November 1, 2016
November 2006
March 2008   (Final data collection date for primary outcome measure)
Absolute change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: 16 weeks ]
Absolute change from baseline in HbA1c at end of treatment
Complete list of historical versions of study NCT00388518 on ClinicalTrials.gov Archive Site
  • Absolute change from baseline in Fasting Plasma Glucose (FPG), HbA1c response rate, insulin sensitivity, beta cell function and cardiovascular markers. [ Time Frame: 16 weeks ]
  • Adverse Events (AEs), laboratory parameters. [ Time Frame: Throughout study ]
Absolute change from baseline in FPG; HbA1c response rate; insulin sensitivity and beta cell function; cardiovascular markers. Safety: AEs, laboratory parameters
Not Provided
Not Provided
 
A Study of Aleglitazar in Patients With Type 2 Diabetes
A Randomized, Double-blind Study to Investigate the Effect of Aleglitazar on Glycemic Control in Patients With Type 2 Diabetes Mellitus.
This 6 arm study will assess the efficacy, safety, tolerability and pharmacokinetics of aleglitazar therapy in patients with Type 2 diabetes. Patients will be randomised to one of 6 treatment arms, to receive one of 4 doses of aleglitazar, Actos as an open-label active comparator, or placebo. Aleglitazar will be administered starting from a dose of 0.05mg po daily, and Actos will be administered at a dose of 45mg once daily. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus Type 2
  • Drug: Actos
    45mg po daily
  • Drug: Placebo
    po daily
  • Drug: aleglitazar
    Administered po daily, at ascending doses with a starting dose (arm 1) of 0.05mg.
  • Active Comparator: Actos
    Intervention: Drug: Actos
  • Experimental: Aleglitazar 1
    Intervention: Drug: aleglitazar
  • Experimental: Aleglitazar 2
    Intervention: Drug: aleglitazar
  • Experimental: Aleglitazar 3
    Intervention: Drug: aleglitazar
  • Experimental: Aleglitazar 4
    Intervention: Drug: aleglitazar
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Henry RR, Lincoff AM, Mudaliar S, Rabbia M, Chognot C, Herz M. Effect of the dual peroxisome proliferator-activated receptor-alpha/gamma agonist aleglitazar on risk of cardiovascular disease in patients with type 2 diabetes (SYNCHRONY): a phase II, randomised, dose-ranging study. Lancet. 2009 Jul 11;374(9684):126-35. doi: 10.1016/S0140-6736(09)60870-9. Epub 2009 Jun 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
332
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes, diagnosed >=1 month of screening;
  • either drug-naive, or pretreated with a maximum of 2 oral antihyperglycemic agents at submaximal doses;
  • HbA1c <=10.0% at screening, and 7.0-10.0% at pre-randomisation visit.

Exclusion Criteria:

  • type 1 diabetes;
  • currently or previously treated with insulin, a thiazolidinedione, or a dual Peroxisome Proliferator Activated Receptor (PPAR) agonist;
  • clinically significant cardiovascular disease;
  • Congestive Heart Failure (CHF) New York Heart Association (NYHA) 3-4.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Greece,   Hong Kong,   Italy,   Mexico,   Romania,   Russian Federation,   Serbia,   United States
China,   Former Serbia and Montenegro,   France
 
NCT00388518
BM17864
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP